When The Overseas Applicant Carries Out Clinical Evaluation Through The Clinical Trial Path, If The Overseas Clinical Trial Data Is Provided, Is It Still Necessary To Carry Out Clinical Trials In China?


Article 5 of the Technical Guiding Principles for Accepting Overseas Clinical Trials of Medical Devices has made it clear that “if relevant requirements for clinical trials are specified in technical review guidelines for specific medical devices, such requirements shall be considered for the overseas clinical trials. When there is inconsistency, sufficient and reasonable evidence and basis shall be provided”. Therefore, if the applicant has submitted clinical trial data conforming to ethical, legal and scientific principles in accordance with this Technical Guiding Principle, and fully considered the differences in technical review requirements, test population and clinical trial conditions, it is not necessary to carry out additional clinical trials in China.